Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
This study is currently recruiting participants.
Verified January 2013 by University Hospital Case Medical Center
Sponsor:
University Hospital Case Medical Center
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
David E. Kemp, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00835120
First received: February 2, 2009
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome Bipolar Depression Insulin Resistance |
Drug: Pioglitazone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance |
Resource links provided by NLM:
Further study details as provided by University Hospital Case Medical Center:
Primary Outcome Measures:
- Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
- Response rates on the IDS-CR, MADRS and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
- Remission rates based on IDS-CR, QIDS-SR, and MADRS scores [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
- Change in Clinical Global Impressions-Bipolar Version (CGI-BP) and Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A) scores [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pioglitazone
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
|
Drug: Pioglitazone
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Other Name: Actos
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be male or female between the ages of 18 and 70
- DSM-IV diagnosis of bipolar disorder (type I, II, or NOS)
- Currently depressed as confirmed by the MINI-Plus at the screening visit
- Currently receiving treatment with an anti-manic drug
- Meets criteria for metabolic syndrome or insulin resistance
Exclusion Criteria:
- Pregnancy or breast feeding
- Unstable or inadequately treated medical illness as judged by the investigator
- Severe personality disorder
- Serious suicidal risk
- Known history of intolerance or hypersensitivity to pioglitazone
- Treatment with pioglitazone in the 3 months prior to randomization
- Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry
- Currently taking an antidiabetic/glucose-lowering agent.
- Diagnosed with dementia
- Acute Mania as defined by a Young Mania Rating Scale (YMRS) score > 15
- Diagnosed with heart failure
- Transaminase elevation >2.5 times the upper limit of normal
- Presence of renal impairment (eg. creatinine > 1.5)
- Fasting blood glucose >150 mg/dL
- Hb A1c > 7.5%
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835120
Contacts
| Contact: Carla Conroy, BA | 216-844-2869 | carla.conroy@uhhospitals.org |
Locations
| United States, Ohio | |
| University Hospitals Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Carla Conroy 216-844-2869 carla.conroy@uhhospitals.org | |
| Principal Investigator: David E Kemp, MD | |
Sponsors and Collaborators
University Hospital Case Medical Center
National Alliance for Research on Schizophrenia and Depression
Takeda Pharmaceuticals North America, Inc.
Investigators
| Principal Investigator: | David E Kemp, MD | Univeristy Hospitals Case Medical Center |
More Information
No publications provided
| Responsible Party: | David E. Kemp, MD, Director, Mood & Metabolic Clinic, University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT00835120 History of Changes |
| Other Study ID Numbers: | 07-08-24 |
| Study First Received: | February 2, 2009 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Insulin Resistance Metabolic Syndrome X Affective Disorders, Psychotic Mood Disorders Mental Disorders |
Behavioral Symptoms Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013